The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Mini One Enteral Extension Set.
| Device ID | K142989 |
| 510k Number | K142989 |
| Device Name: | Mini ONE Enteral Extension Set |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Contact | Joshua Meinke |
| Correspondent | Joshua Meinke APPLIED MEDICAL TECHNOLOGY, INC. 8000 KATHERINE BOULEVARD Brecksville, OH 44141 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-16 |
| Decision Date | 2015-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842071116033 | K142989 | 000 |
| 00842071108687 | K142989 | 000 |
| 00842071108632 | K142989 | 000 |
| 00842071108588 | K142989 | 000 |
| 00842071108496 | K142989 | 000 |
| 00842071108816 | K142989 | 000 |
| 00842071108762 | K142989 | 000 |
| 00842071108748 | K142989 | 000 |
| 00842071108724 | K142989 | 000 |
| 00842071108700 | K142989 | 000 |
| 00842071108663 | K142989 | 000 |
| 00842071108601 | K142989 | 000 |
| 00842071108540 | K142989 | 000 |
| 00842071108519 | K142989 | 000 |
| 00842071129262 | K142989 | 000 |
| 00842071129248 | K142989 | 000 |
| 00842071107659 | K142989 | 000 |
| 00842071107666 | K142989 | 000 |
| 00842071114954 | K142989 | 000 |
| 00842071114947 | K142989 | 000 |
| 00842071114640 | K142989 | 000 |
| 00842071114633 | K142989 | 000 |
| 00842071113643 | K142989 | 000 |
| 00842071113636 | K142989 | 000 |
| 00842071109028 | K142989 | 000 |
| 00842071108786 | K142989 | 000 |
| 00842071109042 | K142989 | 000 |
| 00842071107857 | K142989 | 000 |
| 00842071108946 | K142989 | 000 |
| 00842071108892 | K142989 | 000 |
| 00842071108878 | K142989 | 000 |
| 00842071107703 | K142989 | 000 |
| 00842071107697 | K142989 | 000 |
| 00842071129217 | K142989 | 000 |